학술논문
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'학술논문'
에서 검색결과 40건 | 목록
1~20
Editorial & Opinion
Paul P; EMA, Amsterdam, The Netherlands.; Colin PJ; EMA, Amsterdam, The Netherlands.; Department of Anesthesiology, University Medical Center Groningen, Groningen University, Groningen, The Netherlands.; Musuamba Tshinanu F; FAGG-AFMPS, Brussels, Belgium.; Versantvoort C; MEB, Utrecht, The Netherlands.; Manolis E; EMA, Amsterdam, The Netherlands.; Blake K; EMA, Amsterdam, The Netherlands.
Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE; In Process
Academic Journal
Berg P; Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.; Bakker C; Quality and Safety of Medicines Department, European Medicines Agency (EMA), Amsterdam, The Netherlands. charlotte.bakker@ema.europa.eu.; Sander M; The Danish Medicines Agency, Copenhagen, Denmark.; Hasselblad Lundstrøm N; The Danish Medicines Agency, Copenhagen, Denmark.; Erneholm K; The Danish Medicines Agency, Copenhagen, Denmark.; Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA), Amsterdam, The Netherlands.; Musuamba Tshinanu F; Federal Agency for Medicines and Health Products, Brussels, Belgium.; Kholmanshikh O; Federal Agency for Medicines and Health Products, Brussels, Belgium.; Van Nuffel F; Federal Agency for Medicines and Health Products, Brussels, Belgium.; Müller S; Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.; Ruppert-Seipp G; Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.; Maurer GD; Safety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.; Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA), Amsterdam, The Netherlands.; Januskiene J; Quality and Safety of Medicines Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.; Mantziri M; Quality and Safety of Medicines Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.; Mulder B; Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA), Amsterdam, The Netherlands.; Medicines Evaluation Board, Utrecht, The Netherlands.; van Nimwegen FA; Medicines Evaluation Board, Utrecht, The Netherlands.; Vasilcanu D; Swedish Medical Products Agency, Uppsala, Sweden.; Wändel Liminga U; Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA), Amsterdam, The Netherlands.; Swedish Medical Products Agency, Uppsala, Sweden.
Publisher: Nature Publishing Group Country of Publication: England NLM ID: 9421525 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1476-5462 (Electronic) Linking ISSN: 09697128 NLM ISO Abbreviation: Gene Ther Subsets: MEDLINE
Academic Journal
Paul P; European Medicines Agency, Amsterdam, The Netherlands.; Colin PJ; European Medicines Agency, Amsterdam, The Netherlands.; University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Musuamba Tshinanu F; Federal Agency for Medicines and Health Products, Brussels, Belgium.; University of Namur, Namur, Belgium.; Versantvoort C; Dutch Medicines Evaluation Board, Utrecht, The Netherlands.; Manolis E; European Medicines Agency, Amsterdam, The Netherlands.; Blake K; European Medicines Agency, Amsterdam, The Netherlands.
Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE
Academic Journal
Correia Pinheiro L; European Medicines Agency, Amsterdam, The Netherlands.; Arlett P; European Medicines Agency, Amsterdam, The Netherlands.; Roes K; Radboud University Medical Center, Nijmegen, The Netherlands.; Musuamba Tshinanu F; Federal Agency for Medicines and Health Products, Brussel, Belgium.; Westman G; Medical Products Agency, Uppsala, Sweden.; Frias Z; European Medicines Agency, Amsterdam, The Netherlands.; Hamann H; European Medicines Agency, Amsterdam, The Netherlands.; Berenguer Jornet J; European Medicines Agency, Amsterdam, The Netherlands.; Khan I; The Health Products Authority, Dublin, Ireland.; Larsen J; Danish Medicines Agency, Copenhagen, Denmark.; Broich K; Federal Institute for Drugs and Medical Devices, Bonn, Germany.; Cooke E; European Medicines Agency, Amsterdam, The Netherlands.
Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE; In Process
Academic Journal
Li Z.; Mirams G. R.; Yoshinaga T.; Ridder B. J.; Han X.; Chen J. E.; Stockbridge N. L.; Wisialowski T. A.; Damiano B.; Severi S.; Morissette P.; Kowey P. R.; Holbrook M.; Smith G.; Rasmusson R. L.; Liu M.; Song Z.; Qu Z.; Leishman D. J.; Steidl-Nichols J.; Rodriguez B.; Bueno-Orovio A.; Zhou X.; Passini E.; Edwards A. G.; Morotti S.; Ni H.; Grandi E.; Clancy C. E.; Vandenberg J.; Hill A.; Nakamura M.; Singer T.; Polonchuk L.; Greiter-Wilke A.; Wang K.; Nave S.; Fullerton A.; Sobie E. A.; Paci M.; Musuamba Tshinanu F.; Strauss D. G.
Clin Pharmacol Ther
Clinical Pharmacology & Therapeutics, vol 107, iss 1
Clinical Pharmacology & Therapeutics, vol 107, iss 1
Academic Journal
Frontiers in Pharmacology, Vol 12 (2021)
Academic Journal
Front Pharmacol
Frontiers in Pharmacology, Vol 11 (2020)
Frontiers in Pharmacology, Vol 11 (2020)
Academic Journal
Walenga, Ross L.; Alam, Khondoker; Clarke, James F.; De Backer, Jan; Fridén, Markus; Hamadeh, Abdullah; Mowli, Jay; Sonti, Sujatha; Spires, Jessica; Tan, Ming Liang; Musuamba Tshinanu, Flora; Tsakalozou, Eleftheria
Pharm Res
Walenga, R L, Alam, K, Clarke, JF , De Backer, J, Fridén, M, Hamadeh, A, Mowli, J, Sonti, S, Spires, J, Tan, M L, Musuamba Tshinanu , F & Tsakalozou, E 2025, 'Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products', Pharmaceutical Research, vol. 42, no. 5, pp. 773-784. https://doi.org/10.1007/s11095-025-03823-5
Walenga, R L, Alam, K, Clarke, J
Academic Journal
Marshall S; Clinical Pharmacology Modelling and Simulation, GSK, Stevenage, UK.; Ahamadi M; Clinical Pharmacology Modeling and Simulation, AMGEN, Thousand Oaks, California, USA.; Chien J; Global PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.; Iwata D; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Farkas P; Global Clinical Operations, Teva, Zagreb, Croatia.; Filipe A; Nonclinical and Clinical R&D, Tecnimede SA, Lisbon, Portugal.; Frey N; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.; Greene E; International Regulatory Sciences & Policy, Pfizer, New York, New York, USA.; Kawai N; Clinical Research, Pfizer R&D Japan, Tokyo, Japan.; Li J; National Medical Products Administration, Beijing, China.; Lippert J; Pharmacometrics, Bayer, Berlin, Germany.; Musuamba Tshinanu F; Federal Agency for Medicines and Health Products, Brussels, Belgium and University of Namur, Namur, Belgium.; Manolis E; European Medicines Agency, Amsterdam, The Netherlands.; Peterson MC; Clinical & Quantitative Pharmacology, Vertex Pharmaceuticals, Boston, Massachusetts, USA.; Sarem S; Health Canada/Pharmaceutical Drugs Directorate, Ottawa, Ontario, Canada.; Shebley M; Clinical Pharmacology, AbbVie, North Chicago, Illinois, USA.; Tegenge M; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, USA.; Tsai CH; Center for Drug Evaluation (CDE), Taipei, Taiwan.; Tu CL; Center for Drug Evaluation, Taipei, Taiwan.; Otsubo Y; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Wei J; Novartis Institutes for Biomedical Research Co., Shanghai, China.; Zhang L; Health Canada, Biologic and Radiopharmaceutical Drugs Directorate, Ottawa, Ontario, Canada.; Zhu H; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.; Karlsson KE; Swedish Medical Products Agency, Uppsala, Sweden.
Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE
Academic Journal
Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States.; Musuamba Tshinanu F; Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussels 1210, Belgium.; Raines K; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Borges L; ANVISA, SIA Trecho 5 - Guará, Brasília, DF 71205-050, Brazil.; Kijima S; Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan.; Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, U.K.; Moody R; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St, Ottawa, Ontario K1A 0K9, Canada.; Seo P; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Turner D; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Fang L; Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel CH-4070, Switzerland.; Bransford P; Data and Computational Sciences, Vertex Pharmaceuticals, Inc., Boston, Massachusetts 02210, United States.; Ren X; PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States.; Patel N; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Sperry D; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, United States.; Chen H; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Rostami-Hodjegan A; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Centre for Applied Pharmacokinetic Research, University of Manchester, Stopford Building, Oxford Road, Manchester M139PT, U.K.; Lukacova V; Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534, United States.; Sun D; The University of Michigan, North Campus Research Complex (NCRC), 1600 Huron Parkway, Ann Arbor, Michigan 48109, United States.; Nguefack JF; Head of Biopharmacy Team, Montpellier, Synthetics Platform, Global CMC, Sanofi, Paris 75008, France.; Carducci T; Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave, Rahway, New Jersey 07065, United States.; Grimstein M; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Pepin X; Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534, United States.; Jamei M; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Stamatopoulos K; Biopharmaceutics, DPD, MDS, GlaxoSmithKline, David Jack Centre, Park Road, Ware SG12 0DP, U.K.; Li M; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Sanghavi M; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 43183, Sweden.; Mandula H; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Zhao Z; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Ju TR; Analytical R&D, AbbVie Inc., 1 North Waukegan Road, North Chicago, Illinois 60064, United States.; Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt 64293, Germany.; Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.; Wang M; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States.; Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.; Mitra A; Clinical Pharmacology, Kura Oncology Inc, Boston, Massachusetts 02210, United States.; Kollipara S; Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd., Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090 Telangana, India.; Chirumamilla SK; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States.; Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1543-8392 (Electronic) Linking ISSN: 15438384 NLM ISO Abbreviation: Mol Pharm Subsets: MEDLINE
Academic Journal
Pepin X; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.; Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.; Borges L; ANVISA, SIA Trecho 5́, Guara, Brasília, Federal District 71205-050, Brazil.; Cano-Vega M; Drug Product Technologies, Amgen Inc., Thousand Oaks, California 91320-1799, United States.; Carducci T; Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, New Jersey 07065, United States.; Chatterjee P; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Chen G; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States.; Cristofoletti R; College of Pharmacy, University of Florida, 6550 Sanger Rd., Orlando, Florida 32827, United States.; Dallmann A; Bayer HealthCare SAS, 59000 Lille, France, on behalf of Bayer AG, Pharmacometrics/Modeling and Simulation, Systems Pharmacology & Medicine, PBPK, Leverkusen, Germany.; Delvadia P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Dressman J; Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt am Main 60596, Germany.; Fotaki N; University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom.; Gray E; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States.; Holte Ø; Norwegian Medical Products Agency, Oslo 0213, Norway.; Kijima S; Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan.; Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands.; Lennernäs H; Translational Drug Discovery and Development, Department of Pharmaceutical Bioscience, Uppsala University, Uppsala 751 05, Sweden.; Lindahl A; Swedish Medical Products Agency, Uppsala 752 37, Sweden.; Loebenberg R; Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmontonton T6G 2E1, Canada.; Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.; Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, United Kingdom.; McAllister M; Global Biopharmaceutics, Drug Product Design, Pfizer, Sandwich CT13 9NJ, United Kingdom.; Mitra A; Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts 02210, United States.; Moody R; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Mudie D; Global Research and Development, Small Molecules, Lonza, 63045 NE Corporate Pl., Bend, Oregon 97701, United States.; Musuamba Tshinanu F; Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussel 1210, Belgium.; Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States.; Rege B; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.; Ren X; PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States.; Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.; Scherholz M; Pharmaceutical Development, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, New Jersey 08543, United States.; Song I; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States.; Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland.; Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.; Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 50, Sweden.; Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.; Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa K1A 0K9, Canada.; Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt D-64293, Germany.; Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.
Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1543-8392 (Electronic) Linking ISSN: 15438384 NLM ISO Abbreviation: Mol Pharm Subsets: MEDLINE
Book
Ine Skottheim Rusten; Anna Nordmark; Susan Cole; Joseph F. Standing; Sofia Friberg Hietala; Wei Zhao; Valeria Gigante; Anna Karin Hamberg; Gérard Pons; María Jesús Garrido; Johannes Taminiau; Norbert Benda; Frederike Lentz; Flora Musuamba Tshinanu; Andrew Thomson; Paolo Tomasi; Cecile Ollivier; Ralf Herold; Efthymios Manolis
Fundamentals of Pediatric Drug Dosing ISBN: 9783319437521
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Transplantation Journal. 94:590
Academic Journal
In: Clinical Biochemistry . (Clinical Biochemistry, April 01, 2015, 48(6):401-405)
Academic Journal
Academic Journal
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[검색어] Musuamba Tshinanu, F.
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